(116 days)
The Single Use MultiClip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal / sub-mucosal defects
The proposed device Single Use MultiClip Device is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it has 3 or 5 clips, the 3 or 5 clips could be continuous released by the delivery system.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not describe an AI/ML device or its acceptance criteria and experimental validation.
Therefore, I cannot extract the requested information about acceptance criteria and the study proving a device meets them from this document. The document primarily focuses on the substantial equivalence of a physical medical device (Single Use MultiClip Device) to a predicate device based on its design, materials, manufacturing processes, intended use, and performance/bench testing, rather than the performance of an AI algorithm.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.